Body lumen device anchor, device and assembly

ABSTRACT

An anchor anchors a therapeutic device having an elongated body within a body lumen. The anchor includes a fixation member carried on the device which is adjustable from a first configuration that permits placement of the device in the body lumen to a second configuration that anchors the device within the body lumen. The anchor further includes a lock that locks the fixation member in the second configuration. The fixation member may be locked in any one of a plurality of intermediate points between the first configuration and a maximum second configuration.

CROSS-REFERENCE

This application is a divisional application of Ser. No. 10/142,637,filed May 8, 2002 now U.S. Pat No. 6,824,562,which is incorporatedherein by reference in its entirety and to which application we claimpriority under 35 USC § 120.

FIELD OF THE INVENTION

The present invention generally relates to an anchor for use with adevice which requires anchoring in a body lumen. The present inventionmore particularly relates to a mitral valve annulus device and assemblywherein the device is deployed and anchored in the coronary sinus of aheart adjacent the mitral valve annulus to reshape the mitral valveannulus.

BACKGROUND OF THE INVENTION

The human heart generally includes four valves. Of these valves, a mostcritical one is known as the mitral valve. The mitral valve is locatedin the left atrial ventricular opening between the left atrium and leftventricle. The mitral valve is intended to prevent regurgitation ofblood from the left ventricle into the left atrium when the leftventricle contracts. In preventing blood regurgitation the mitral valvemust be able to withstand considerable back pressure as the leftventricle contracts.

The valve cusps of the mitral valve are anchored to muscular wall of theheart by delicate but strong fibrous cords in order to support the cuspsduring left ventricular contraction. In a healthy mitral valve, thegeometry of the mitral valve ensures that the cusps overlie each otherto preclude regurgitation of the blood during left ventricularcontraction.

The normal functioning of the mitral valve in preventing regurgitationcan be impaired by dilated cardiomyopathy caused by disease or certainnatural defects. For example, certain diseases may cause dilation of themitral valve annulus. This can result in deformation of the mitral valvegeometry to cause ineffective closure of the mitral valve during leftventricular contraction. Such ineffective closure results in leakagethrough the mitral valve and regurgitation. Diseases such as bacterialinflammations of the heart or heart failure can cause the aforementioneddistortion or dilation of the mitral valve annulus. Needless to say,mitral valve regurgitation must not go uncorrected.

One method of repairing a mitral valve having impaired function is tocompletely replace the valve. This method has been found to beparticularly suitable for replacing a mitral valve when one of the cuspshas been severely damaged or deformed. While the replacement of theentire valve eliminates the immediate problem associated with a dilatedmitral valve annulus, presently available prosthetic heart valves do notpossess the same durability as natural heart valves.

Various other surgical procedures have been developed to correct thedeformation of the mitral valve annulus and thus retain the intactnatural heart valve function. These surgical techniques involverepairing the shape of the dilated or deformed valve annulus. Suchtechniques, generally known as annuloplasty, require surgicallyrestricting the valve annulus to minimize dilation. Here, a prosthesisis typically sutured about the base of the valve leaflets to reshape thevalve annulus and restrict the movement of the valve annulus during theopening and closing of the mitral valve.

Many different types of prostheses have been developed for use in suchsurgery. In general, prostheses are annular or partially annular shapedmembers which fit about the base of the valve annulus. The annular orpartially annular shaped members may be formed from a rigid material,such as a metal, or from a flexible material.

While the prior art methods mentioned above have been able to achievesome success in treating mitral regurgitation, they have not beenwithout problems and potential adverse consequences. For example, theseprocedures require open heart surgery. Such procedures are expensive,are extremely invasive requiring considerable recovery time, and posethe concomitant mortality risks associated with such procedures.Moreover, such open heart procedures are particularly stressful onpatients with a compromised cardiac condition. Given these factors, suchprocedures are often reserved as a last resort and hence are employedlate in the mitral regurgitation progression. Further, the effectivenessof such procedures is difficult to assess during the procedure and maynot be known until a much later time. Hence, the ability to makeadjustments to or changes in the prostheses to obtain optimumeffectiveness is extremely limited. Later corrections, if made at all,require still another open heart surgery.

An improved therapy to treat mitral regurgitation without resorting toopen heart surgery has recently been proposed. This is rendered possibleby the realization that the coronary sinus of a heart is near to and atleast partially encircles the mitral valve annulus and then extends intoa venous system including the great cardiac vein. As used herein, theterm “coronary sinus” is meant to refer to not only the coronary sinusitself but in addition, the venous system associated with the coronarysinus including the great cardiac vein. The therapy contemplates the useof a device introduced into the coronary sinus to reshape andadvantageously effect the geometry of the mitral valve annulus.

The device includes a resilient member having a cross sectionaldimension for being received within the coronary sinus of the heart anda longitudinal dimension having an unstressed arched configuration whenplaced in the coronary sinus. The device partially encircles and exertsan inward pressure on the mitral valve. The inward pressure constrictsthe mitral valve annulus, or at least a portion of it, to essentiallyrestore the mitral valve geometry. This promotes effective valve sealingaction and eliminates mitral regurgitation.

The device may be implanted in the coronary sinus using onlypercutaneous techniques similar to the techniques used to implantcardiac leads such as pacemaker leads. One proposed system forimplanting the device includes an elongated introducer configured forbeing releasably coupled to the device. The introducer is preferablyflexible to permit it to advance the device into the heart and into thecoronary sinus through the coronary sinus ostium. To promote guidance,an elongated sheath is first advanced into the coronary sinus. Then, thedevice and introducer are moved through a lumen of the sheath until thedevice is in position within the coronary sinus. Because the device isformed of resilient material, it conforms to the curvatures of the lumenas it is advanced through the sheath. The sheath is then partiallyretracted to permit the device to assume its unstressed archedconfiguration. Once the device is properly positioned, the introducer isthen decoupled from the device and retracted through the sheath. Theprocedure is then completed by the retraction of the sheath. As aresult, the device is left within the coronary sinus to exert the inwardpressure on the mitral valve to restore mitral valve geometry.

The foregoing therapy has many advantages over the traditional openheart surgery approach. Since the device, system and method may beemployed in a comparatively noninvasive procedure, mitral valveregurgitation may be treated at an early stage in the mitralregurgitation progression. Further, the device may be placed withrelative ease by any minimally invasive cardiologist. Still further,since the heart remains completely intact throughout the procedure, theeffectiveness of the procedure may be readily determined. Moreover,should adjustments be deemed desirable, such adjustments may be madeduring the procedure and before the patient is sent to recovery.

Another approach to treat mitral regurgitation with a device in thecoronary sinus is based upon the observation that the application of alocalized force against a discrete portion of the mitral valve annuluscan terminate mitral regurgitation. This suggests that mitralregurgitation may be localized and nonuniform. Hence, the device appliesa force to one or more discrete portions of the atrial wall of thecoronary sinus to provide localized mitral valve annulus reshapinginstead of generalized reshaping of the mitral valve annulus. Suchlocalized therapy would have all the benefits of the generalizedtherapy. In addition, a localized therapy device may be easier toimplant and adjust.

A still further approach to treat mitral regurgitation from the coronarysinus of the heart contemplates a device having a first anchorconfigured to be positioned within and fixed to the coronary sinus ofthe heart adjacent the mitral valve annulus within the heart, a cablefixed to the first anchor and extending proximally from the first anchorwithin the heart, a second anchor configured to be positioned in andfixed in the heart proximal to the first anchor and arranged toslidingly receive the cable, and a lock that locks the cable on thesecond anchor. When the first and second anchors are fixed within theheart, the cable may be drawn proximally and locked on the secondanchor. The geometry of the mitral valve is thereby effected. Thisapproach provides flexibility in that the second anchor may bepositioned and fixed in the coronary sinus or alternatively, the secondanchor may be positioned and fixed in the right atrium. This approachfurther allows adjustments in the cable tension after implant.

A still further alternative for treating mitral regurgitationcontemplates a device having a first anchor configured to be positionedwithin and anchored to the coronary sinus of the heart adjacent themitral valve annulus within the heart. A second anchor is configured tobe positioned within the heart proximal to the first anchor and adjacentthe mitral valve annulus within the heart. A connecting member, having afixed length, is permanently attached to the first and second anchors.As a result, when the first and second anchors are within the heart withthe first anchor anchored in the coronary sinus, the second anchor maybe displaced proximally to effect the geometry of the mitral valveannulus and released to maintain the effect on the mitral valvegeometry. The second anchor may be configured, when deployed, to anchoragainst distal movement but be moveable proximally to permit the secondanchor to be displaced proximally within the coronary sinus.

A further device that effects the condition of a mitral valve annulus ofa heart also includes an elongated member dimensioned to be placed inthe coronary sinus of the heart adjacent the mitral valve annulus. Here,the elongated member is flexible when placed in the heart in a firstorientation to position the device in the coronary sinus adjacent themitral valve annulus and relatively inflexible when rotated into asecond orientation after the device is positioned in the coronary sinusadjacent to the mitral valve annulus.

The device thus has a first radius of curvature when in the firstorientation and a second and greater radius of curvature when in thesecond orientation to effect the mitral valve geometry. Once positionedand in the second orientation, the device is anchored against bothlongitudinal and rotational movement.

Devices, other than those described above may be placed in body lumensother than the coronary sinus for therapeutic effect. All such devicesmust be anchored against movement when deployed at least for an acutephase until the natural body mechanisms produce sufficient fibrotictissue about the devices for permanent fixation. While the deviceanchors must protect against device movement, they must also allow readydeployment to facilitate device implant. However, it is desirable thatthe anchors also be readily releasable, at least during the acute phaseto permit device position adjustment or even device removal if required.All of these factors are especially important for devices implanted inthe heart because of the potential need for precise device positioningduring implant and the extreme movement of the heart during heartbeats.

SUMMARY OF THE INVENTION

The invention provides an anchor that anchors a device having anelongated body in a body lumen. The anchor includes a fixation membercarried on the device, the fixation member being adjustable from a firstconfiguration that permits placement of the device in the body lumen toa second configuration that anchors the device within the body lumen,and a lock that locks the fixation member in the second configuration.

The lock is releasable to release the fixation member from the secondconfiguration to permit the device to be removed from the body lumen.The fixation member may also be deformable to permit the device to bemoved within the body lumen.

The fixation member is adjustable from the first configuration to amaximum second configuration. The lock may be configured to lock thefixation member at any one of a plurality of intermediate points betweenthe first configuration and the maximum second configuration.

The fixation member may be elongated and have a first end hingedlycoupled to the device body. The fixation member may thus extend alongthe device body closely spaced to the device body when in the firstconfiguration and be pivoted from the device body to the secondconfiguration to engage and anchor the device in the body lumen.

The anchor may further include a support that renders the fixationmember substantially rigid when in the second configuration. The supportmay be an extension of the fixation member, wherein the fixation memberincludes a second end opposite the first end and wherein the lock locksthe fixation member second end on the device body.

The fixation member may include a second end opposite the first end. Thesupport may include a support member having a first end hingedly coupledto the fixation member second end and a second end opposite, the supportmember first end. The lock may lock the support member second end on thedevice body. The support member second end may be slidable along thedevice body. The anchor may include a plurality of the fixation membersand/or a plurality of support members.

The invention further provides a device that effects the condition of amitral valve annulus of a heart. The device includes an elongated bodydimensioned to be placed in the coronary sinus of the heart adjacent themitral valve annulus. The device further includes a fixation membercarried by the device, the fixation member being adjustable from a firstconfiguration that permits placement of the device in the coronary sinusto a second configuration that anchors the device within the coronarysinus, and a lock that locks the fixation member in the secondconfiguration.

The lock is releasable to release the fixation member from the secondconfiguration to permit the device to be moved within the coronarysinus. The fixation member may be deformable to permit the device to bemoved within the coronary sinus.

The fixation member may be adjustable from the first configuration to amaximum second configuration and the lock may lock the fixation memberat any one of a plurality of intermediate points between the firstconfiguration and the maximum second configuration.

The fixation member is elongated and has a first end hingedly coupled tothe device body. The fixation member may extend along the device bodyclosely spaced to the device body when in the first configuration andmay be pivoted from the device body when in the second configuration toengage the coronary sinus and anchor the device in the coronary sinus.The device may further include a support that renders the fixationmember substantially rigid when in the second configuration. The supportmay be an extension of the fixation member, wherein the fixation memberincludes a second end opposite the first end and wherein the lock locksthe fixation member second end on the device body. The fixation membersecond end may be slidable along the device body and the device mayinclude a plurality of the fixation members.

The fixation member may include a second end opposite the first end. Thesupport may be a separate support member having a first end hingedlycoupled to the fixation member second end and second end opposite thesupport member first end. The lock may then lock the support membersecond end on the device body. The support member second end may beslidable along the device body. The device may include a plurality ofthe fixation members and support members.

The invention further provides an assembly that effects the condition ofa mitral valve annulus of a heart. The assembly includes a mitral valvetherapy device dimensioned to be placed in the coronary sinus adjacentthe mitral valve annulus. The device includes an elongated body, afixation member carried by the device, the fixation member beingadjustable from a first configuration that permits placement of thedevice in the coronary sinus to a second configuration that anchors thedevice within the coronary sinus, and a lock that locks the fixationmember in the second configuration. The assembly further includes aflexible catheter having a lumen that receives the device and beingdimensioned to be advanced into the coronary sinus to place the deviceadjacent the coronary sinus.

The assembly may further include an elongated pusher that is received bythe lumen of the catheter proximal to the device and that permits thedevice and the catheter to be moved opposite each other. The assemblymay further include a tether receivable by the catheter lumen andengagable with the device to pull the device distally with respect tothe catheter. The catheter may be used to transition the fixation memberfrom the first configuration to the second configuration. For example,the fixation member may be elongated and have a first end hingedlycoupled to the device body. The fixation member may then extend alongthe device body when in the first configuration and the fixation membermay be pivoted from the device body into the second configuration bydistal movement of the catheter with respect to the device to cause thefixation member to engage the coronary sinus and anchor the device inthe coronary sinus.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further aspects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a superior view of a human heart with the atria removed;

FIG. 2 is a superior view of a human heart similar to FIG. 1illustrating a mitral valve therapy device including an anchor embodyingthe present invention deployed therein along with an assembly embodyingthe present invention for deploying the device;

FIG. 3 is a side view with portions cut away illustrating a first stepin deploying the device anchor of the device of FIG. 2;

FIG. 4 is a side view similar to FIG. 3 illustrating a further step inthe deployment of the anchor embodying the present invention;

FIG. 5 is a side view similar to FIG. 3 illustrating a further step inthe deployment of the device anchor;

FIG. 6 is a side view similar to FIG. 3 illustrating the deployed deviceanchor;

FIG. 7 is a side view similar to FIG. 3 illustrating a first step in theremoval of the device anchor;

FIG. 8 is a side view similar to FIG. 3 illustrating a final step in theremoval of the device anchor;

FIG. 9 is a side view similar to FIG. 3 illustrating an alternateembodiment of a deployed device anchor embodying the present invention;

FIG. 10 is a side view similar to FIG. 3 illustrating a furtherembodiment of a deployed device anchor embodying the present invention;

FIG. 11 is a side view similar to FIG.3 illustrating a still furtherembodiment of a deployed device anchor embodying the present invention;and

FIG. 12 is an end view of FIG. 11.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, it is a superior view of a human heart 10 withthe atria removed to expose the mitral valve 12, the coronary sinus 14,the coronary artery 15, and the circumflex artery 17 of the heart 10 tolend a better understanding of the present invention. Also generallyshown in FIG. 1 are the pulmonary valve 22, the aortic valve 24, and thetricuspid valve 26 of the heart 10.

The mitral valve 12 includes an anterior cusp 16, a posterior cusp 18and an annulus 20. The annulus encircles the cusps 16 and 18 andmaintains their spacing to provide a complete closure during a leftventricular contraction. As is well known, the coronary sinus 14partially encircles the mitral valve 12 adjacent to the mitral valveannulus 20. As is also known, the coronary sinus is part of the venussystem of the heart and extends along the AV groove between the leftatrium and the left ventricle. This places the coronary sinusessentially within the same plane as the mitral valve annulus making thecoronary sinus available for placement of the mitral valve therapydevice of the present invention therein.

FIG. 2 shows a mitral valve therapy device 30 embodying the presentinvention shown deployed in the coronary sinus 14 of the heart 10adjacent the mitral valve annulus 20 for effecting the geometry of themitral valve annulus. Also shown in FIG. 2 is a deployment system 50that deploys the device 30 in the coronary sinus 14. The device 30 takesthe form of an elongated body 32 which includes a distal anchor 34embodying the present invention and a proximal anchor 36.

The anchors 34 and 36 are shown in FIG. 2 in their deployedconfiguration. As will be seen hereinafter, upon deployment of thedevice 30 in the coronary sinus, the distal anchor 34 is transitionedfrom a first configuration to a locked second configuration. In theprocess, it is expanded outwardly to anchor the device in the coronarysinus against both bi-directional longitudinal and rotational movement.The proximal anchor however, when deployed, is configured to permitproximal movement. This allows the device 30 to be tightened within thecoronary sinus by proximal pulling of the anchor 36 after the distalanchor 34 is deployed. The device 30 may be formed from Nitinol orstainless steel, for example.

The deployment system 52 illustrated in FIG. 2 includes an elongatedcatheter 50, an elongated pusher 54, and a tether 56. In deploying thedevice 30, the tether 56 is first looped about the proximal anchor 36 ofthe device 30 as illustrated and the device is then loaded into thecatheter 50. The tether 56 is then threaded through an internal lumen 58of the pusher 54 and looped around the proximal anchor 36 of the device30 as illustrated. The pusher 54 is then advanced along the tether 56for engaging the device 30 and pushing the device distally down thecatheter to a predetermined position at the distal end of the catheter50. The catheter with the device 30 loaded therein is then fed into theheart and through the coronary sinus ostium 31 into the coronary sinusto place the catheter in a position such that the device 30 is adjacentthe mitral valve annulus 20. Thereafter, the device is maintained in astationary position by the pusher 54 as the catheter 50 is partiallywithdrawn to expose the distal anchor 34. Once the distal anchor isexposed, it is deployed by the catheter in a manner to be described moreparticularly with respect to FIGS. 3-6. Once the distal anchor 34 isdeployed, the catheter 50 is then retracted proximally of the proximalanchor 36. This exposes the proximal anchor 36 and permits the proximalanchor to self deploy. Once the proximal anchor is deployed, the tether56 is pulled proximally to move the proximal anchor 36 in a proximaldirection for tightening the device within the coronary sinus and to anextent which results in the desired effect on the geometry of the mitralvalve annulus 20. During this adjustment process, mitral regurgitationmay be monitored and the device adjusted for optimal results. When thedevice 30 is in its final position within the coronary sinus 14, thepusher 54 and catheter 50 may be removed from the heart. The tether 56may be permitted to remain in the heart during an acute phase toascertain the effectiveness of the device 30. Should further adjustmentof the device be necessary, the tether 56 may then be used as a guidefor guiding the introduction of the catheter 50 back into the heart.

FIGS. 3-6 illustrate the manner in which the distal anchor 34 may bedeployed in the coronary sinus 14 for anchoring the device 30. It willbe appreciated by those skilled in the art, of course, that the anchor34 may be utilized in body lumens other than the coronary sinus and withtherapeutic devices other than the mitral valve annulus therapy deviceillustrated in FIG. 2.

In each of FIGS. 3-6 a portion of the coronary sinus has been removedand the pusher has not been illustrated so as to not unduly complicatethe figures. FIG. 3 shows the catheter 50 disposed within the coronarysinus 14 with the device 30 and distal anchor within the catheter 50. Tothat end, the catheter includes a lumen 60 which is dimensioned toreceive the device 30 and the distal anchor 34 when the distal anchor 34is in a first configuration. The distal anchor 34 includes an elongatedfixation member 38 which is hingedly coupled to the distal end of thedevice 30 at a hinge 40. The elongated fixation member thus extendsalong the body of the device 30. The fixation member includes a support42 which is an extension of the fixation member 38 and which is hingedlyconnected to the fixation member 38 at a hinge point 44. The proximalend of the fixation member 38 includes a loop 46 which is looped aboutthe device 30 to permit the loop 46 to slide along the device 30. Aswill be seen subsequently, the loop 46 forms part of a lock for lockingthe anchor 34 in a second configuration for anchoring in the coronarysinus.

To complete the anchor, the device 30 includes a resilient enlargedportion 48 over which the loop 46 may slide. Once the loop 46 is locateddistally of the enlarged portion 48, it will be held by the enlargedportion 48 for locking the device in the second configuration.

FIG. 4 illustrates the anchor 34 after the catheter 50 has been movedproximal to the anchor 34. More specifically, it will be noted that thedistal end of the catheter 50 is now proximal to the loop 46 or proximalend of the anchor 34. The shape memory of the anchor has caused theanchor to expand and is now partially transitioned from the firstconfiguration of FIG. 3 to the second and final configuration to bedescribed with reference to FIG. 6 subsequently.

FIG. 5 illustrates the anchor 34 being transitioned from the firstconfiguration to the second configuration. This transition isimplemented by the distal end of the catheter 50 pushing the proximalend of the anchor 34 in the distal direction. To maintain the positionof the anchor 34 during the transition, the tether 56 is used to holdthe device 30 against distal movement.

The particular configuration of the distal anchor 34 in accordance withthis embodiment may be more particularly seen in FIG. 5. Here it may beseen that the distal anchor is formed of a wire having a first endsecured to the distal end of the device 30, folded back and loopedaround the device and then back to the distal end of the device. Bothends of the anchor are then crimped by a crimp 70. This configurationresults in a pair of fixation members 38 each having a support extension42. In addition, the fixation members 38 may be formed so as to have aloop configuration to maximize surface contact with the inner wall ofthe coronary sinus 14.

As the catheter 50 is moved distally, it forces the loop 46 of theanchor 34 over the enlarged portion 48 of the device 30 to a pointdistal to the enlarged portion 48. This locks the loop 46 distally ofthe enlarged portion 48 for locking the anchor 34 in an enlarged secondconfiguration as illustrated in FIG. 6 to anchor the device 30 withinthe coronary sinus 14. More specifically, it may be seen that thesupports 42 have been pivoted at the hinge 44 relative to the fixationmember 38. This allows the fixation members 38 to be supported by thesupports 42 and securely locked by the lock of the loop 46 and enlargedportion 48 of the device 30. The fixation members 38 provide broadsurface contact with the inner wall of the coronary sinus 14. Thisprovides for anchoring within the coronary sinus of the device 30against both bi-directional longitudinal and rotational movement. Oncethe anchor 34 is deployed as illustrated in FIG. 6, the catheter 50 maythen be removed as indicated by the arrow 72.

One of the many features of the anchor of the instant invention is thatit may be moved within or removed from the body lumen in which it isdeployed. More specifically, and making reference to FIG. 6, the anchor34 may be removed by grabbing the support members 42 and pulling theloop 46 over the resilient enlarged portion 48 of the device 30. Whenthe loop 46 is on the proximal side of the enlarged portion 48, furtherproximal movement of the loop 46 will fully transition the anchor 34from the second configuration back to the first configuration forremoval within the catheter 50.

Alternatively, by virtue of the support members, the anchor 34 may beformed of deformable material such as stainless steel. Using this toadvantage, the anchor 34 may be partially collapsed by the catheter 50to permit the anchor 34 and hence the device 30 to be moved andrepositioned in the coronary sinus after which the resilience of theanchor material returns the anchor to its locked and deployedconfiguration. The anchor may be collapsed by the catheter 50 asillustrated in FIGS. 7 and 8.

In FIG. 7, it will be noted that the catheter 50, while the device isheld stationary by the tether, is moved distally over the enlargedportion 48 and the loop 46. The anchor 34 is now partially collapsed formovement and repositioning. Once repositioned, the catheter may bewithdrawn to redeploy the anchor 34 which returns to its secondconfiguration by virtue of its resiliency and shape memory.

As seen in FIG. 8, continued distal movement of the catheter 50 causesthe anchor 34 to fully collapse. This allows the anchor 34 to be totallydrawn into the catheter 50. Once the anchor 34 is collapsed and withinthe catheter 50, the device 30 may be removed by removing the catheterwith the device therein or by pulling the device proximally through thecatheter.

FIGS. 9-12 illustrate alternative embodiments of the anchor of thepresent invention. These embodiments are once again illustrated inconnection with the anchoring of a mitral valve annulus therapy devicewithin the coronary sinus of a heart.

In FIG. 9, the device 30 is shown having a plurality of enlargedportions 46. As a result, a plurality of locks are provided on thedevice 30 to enable the fixation members to be locked at any one of aplurality of intermediate points between the first configuration and amaximum second configuration illustrated in FIG. 9. This enables theanchor 34 to be sized to a given body lumen.

FIG. 10 shows another anchor 84 embodying the present invention whichhas a separate fixation member 88 and support member 92. The second ordistal end of the fixation member 88 is hingedly coupled to a first ordistal end of the support member 92 by a hinged connection 94. Thefixation member 88 may have a hoop configuration as the fixation members38 previously described.

FIGS. 11 and 12 illustrated a still further anchor 104 having a pair offixation members 108 and corresponding separate support members 112.Here, the fixation members 108 are formed by immediately adjacent anchorwires which, as best seen in FIG. 12, are disposed at an angle to permita cardiac lead, indicated by the dashed circle 120, to pass through theanchor and thus be within the coronary sinus. Hence, a device having ananchor such as anchor 104 is compatible with the provision of a cardiaclead therewith.

As can thus been seen, the present invention provides a new and improvedanchor for anchoring a therapeutic device within a body lumen. Theanchor of the present invention, by virtue of the lockable supportmember, creates mechanical advantage to assist deployment of the anchor.This also increases anchor strength. Because the support members may beof hooped or looped configuration, increased contact area between theanchor and the body lumen can be achieved. In addition, the anchor ofthe present invention allows deactivation and repositioning of theanchor or therapeutic device incorporating the anchor. Still further,because of the locked support structure, the anchor may be formed ofsmaller diameter wire, tube wall, or other materials which without thelocked support provided by the anchor of the present invention would beunsuitable for this application.

While particular embodiments of the present invention have been shownand described, modifications may be made. It is therefore intended inthe appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

1. A device that effects the condition of a mitral valve annulus of aheart comprising: an elongated body dimensioned to be placed in thecoronary sinus of the heart adjacent the mitral valve annulus; afixation member carried by the device, the fixation member beingadjustable from a first configuration that permits placement of thedevice in the coronary sinus to a maximum second configuration thatanchors the device within the coronary sinus; and a lock that locks thefixation member in the second configuration and intermediate the firstconfiguration and the second configuration; wherein the fixation memberis elongated and has a first end hingedly coupled to the device body,wherein the fixation member extends along the device body closely spacedto the device body when in the first configuration and wherein thefixation member is pivoted from the device body when in the secondconfiguration to engage the coronary sinus and anchor the device in thecoronary sinus.
 2. The device of claim 1 wherein the lock is releasableto release the fixation member to permit the device to be moved withinthe coronary sinus.
 3. The device of claim 1 wherein the fixation memberis deformable to permit the device to be moved within the coronarysinus.
 4. The device of claim 1 wherein the lock locks the fixationmember at any one of a plurality of intermediate points between thefirst configuration and the maximum second configuration.
 5. The deviceof claim 1 further comprising a support that renders the fixation membersubstantially rigid when in the second configuration.
 6. The device ofclaim 5 wherein the support is an extension of the fixation member,wherein the fixation member includes a second end opposite the first endand wherein the lock locks the fixation member second end on the devicebody.
 7. The device of claim 6 wherein the fixation member second end isslidable along the device body.
 8. The device of claim 6 wherein thedevice comprises a plurality of the fixation members.
 9. An assemblythat effects the condition of a mitral valve annulus of a heart, theassembly comprising: a mitral valve therapy device dimensioned to beplaced in the coronary sinus adjacent the mitral valve annulus, thedevice including an elongated body, a fixation member carried by thedevice, the fixation member being adjustable from a first configurationthat permits placement of the device in the coronary sinus to a maximumsecond configuration that anchors the device within the coronary sinus,and a lock that locks the fixation member in the second configurationand intermediate the first configuration and the second configuration; aflexible catheter having a lumen that receives the device and beingdimensioned to be advanced into the coronary sinus to place the deviceadjacent the coronary sinus, the catheter transitioning the fixationmember from the first configuration to the second configuration; and atether receivable by the catheter lumen and engageable with the deviceto pull the device proximally with respect to the catheter; wherein thefixation member is elongated and has a first end hingedly coupled to thedevice body, wherein the fixation member extends along the device bodywhen in the first configuration and wherein the fixation member ispivoted from the device body into the second configuration by distalmovement of the catheter with respect to the device to engage thecoronary sinus and anchor the device in the coronary sinus.
 10. Theassembly of claim 9 wherein the lock locks the fixation member at anyone of a plurality of intermediate points between the firstconfiguration and the maximum second configuration.
 11. The assembly ofclaim 9 further comprising an elongated pusher that is received by thelumen of the catheter proximal to the device and that permits the deviceand the catheter to be moved opposite each other.
 12. The assembly ofclaim 9 wherein the device further comprises a support that renders thefixation member substantially rigid when in the second configuration.13. The assembly of claim 12 wherein the support is an extension of thefixation member, wherein the fixation member includes a second endopposite the first end and wherein the lock locks the fixation membersecond end on the device body when the fixation member second end is ina locked position.
 14. The assembly of claim 13 wherein the fixationmember second end is slidable along the device body by the catheter intothe locked position.
 15. The assembly of claim 13 wherein the devicecomprises a plurality of the fixation members.
 16. The assembly of claim9 wherein the lock is releasable to release the fixation member topermit the device to be removed from the coronary sinus.
 17. Theassembly of claim 9 wherein the fixation member is deformable to permitthe device to be moved within the coronary sinus.
 18. A device thatanchors in a body lumen, the device comprising an anchor and anelongated body dimensioned to be placed in the body lumen, the anchorcomprising: a fixation member, the fixation member being adjustable froma first configuration that permits placement of the device in the bodylumen to a maximum second configuration that anchors the device withinthe body lumen; and a lock that locks the fixation member in the secondconfiguration and intermediate the first configuration and the maximumsecond configuration; wherein the fixation member is elongated and has afirst end hingedly coupled to the device body, wherein the fixationmember extends along the device body closely spaced to the device bodywhen in the first configuration and wherein the fixation member ispivoted from the device body when in the second configuration to engagethe body lumen and anchor the device in the body lumen, the anchorfurther comprising a support that renders the fixation membersubstantially rigid when in the second configuration.
 19. The device ofclaim 18 wherein the lock is releasable to release the fixation memberto permit the device to be moved within the body lumen.
 20. The deviceof claim 18 wherein the fixation member is deformable to permit thedevice to be moved within the body lumen.
 21. The device of claim 18wherein the lock locks the fixation member at any one of a plurality ofintermediate points between the first configuration and the maximumsecond configuration.
 22. The device of claim 18 wherein the support isan extension of the fixation member, wherein the fixation memberincludes a second end opposite the first end and wherein the lock locksthe fixation member second end on the device body.
 23. The device ofclaim 22 wherein the fixation member second end is slidable along thedevice body.
 24. The device of claim 22 comprising a plurality of thefixation members.